U.S. patent application number 13/707272 was filed with the patent office on 2014-06-12 for lumen occluding stent, delivery catheter and method.
The applicant listed for this patent is Bandula Wijay. Invention is credited to Bandula Wijay.
Application Number | 20140163599 13/707272 |
Document ID | / |
Family ID | 50853518 |
Filed Date | 2014-06-12 |
United States Patent
Application |
20140163599 |
Kind Code |
A1 |
Wijay; Bandula |
June 12, 2014 |
Lumen Occluding Stent, Delivery Catheter and Method
Abstract
A permanent acute occlusion implantable device and method are
described for immediate occlusion of a body lumen, such as blood
vessels and the fallopian tubes of the human female, wherein an
balloon expandable lumen occlusion device is placed within the
lumen to be occluded. After inflating the balloon, the balloon is
withdrawn leaving the expanded occlusion device in the lumen. The
device is encased in an occluding impervious sheath and therefore
completely occludes the lumen once the device is delivered and
anchored into the inner wall of the body lumen.
Inventors: |
Wijay; Bandula;
(Friendswood, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Wijay; Bandula |
Friendswood |
TX |
US |
|
|
Family ID: |
50853518 |
Appl. No.: |
13/707272 |
Filed: |
December 6, 2012 |
Current U.S.
Class: |
606/192 |
Current CPC
Class: |
A61B 17/12109 20130101;
A61B 17/12031 20130101; A61B 17/12172 20130101; A61B 2017/12081
20130101; A61F 6/22 20130101; A61B 17/12 20130101 |
Class at
Publication: |
606/192 |
International
Class: |
A61B 17/12 20060101
A61B017/12 |
Claims
1. A lumen occluding assembly, comprising: an expandable tubular
body having proximal and distal ends defining a passage
therethrough and having a smaller dimension for delivery and a
larger dimension for contact of the surrounding lumen; a sheath
covering said passage so as to occlude the lumen when said body is
at said larger dimension.
2. The assembly of claim 1, wherein: said expandable tubular body
having an outer wall and said sheath extends over at least a
portion of said outer wall so that said sheath contacts the lumen
in the larger dimension of said expandable tubular body.
3. The assembly of claim 1, wherein: said expandable tubular body
is formed having scores or openings when in said smaller
dimension.
4. The assembly of claim 3, wherein: said scores open to form
openings when said expandable tubular body is in said larger
dimension.
5. The assembly of claim 1, wherein: said expandable tubular body
is brought from said smaller to said larger dimension with an
inflatable member selectively located within said passage.
6. The assembly of claim 5, wherein: said inflatable member is
removably mounted in said passage and secured to a distal end of a
delivery member, said delivery member having a neck adjacent said
inflatable member.
7. The assembly of claim 5, wherein: said expandable tubular body
further comprises adjacent a distal end thereof a plurality of
spaced generally axially extending struts supporting an axially
extending flexible guide wire.
8. The assembly of claim 7, wherein: said sheath covers said
struts.
9. The assembly of claim 2, wherein: said sheath is located over
said distal end of said expandable tubular body.
10. The assembly of claim 1, wherein: said expandable tubular body
further comprising opposed proximal and distal sinusoidal elongated
member rings connected by a plurality of circumferentially spaced
struts, said struts defining open areas therebetween for fixation
by prolapsed of tissue defining an inner wall of the lumen.
11. The assembly of claim 10, wherein: said sheath is mounted over
said distal sinusoidal ring.
12. The assembly of claim 5, wherein: said inflatable member has a
larger proximal dimension when inflated so that said proximal end
of said expandable tubular body in said larger dimension of said
expandable tubular body has a larger proximal end dimension than
the remainder of said expandable tubular body.
13. The assembly of claim 5, wherein: said inflatable member has a
smaller or larger dimension when inflated between a proximal and
distal end thereof so that upon inflation said proximal and distal
ends of said expandable tubular body have a larger or smaller
peripheral dimension than another portion between said proximal and
distal ends of said expandable tubular body.
14. The assembly of claim 5, wherein: said expandable tubular body
is formed from sinusoidally wound elongated members forming
attached axially stacked and connected rings, said rings expandable
to different peripheral dimensions between proximal and distal ends
of said body to allow said body to be fixated with respect to a
uterus at said proximal end and a fallopian tube.
15. The assembly of claim 3, wherein: said sheath covers at least
some of said openings.
16. The assembly of claim 1, wherein: said lumen is occluded when
said body reaches said larger dimension placing said sheath in
contact with the lumen.
17. The assembly of claim 10, wherein: said sinusoidal elongated
member rings are disposed in said smaller dimension by layering of
a first oppositely disposed bend pair over a second bend pair
circumferentially offset from said first bend pair.
18. The assembly of claim 14, wherein: said sinusoidal elongated
member rings are disposed in said smaller dimension by layering of
a first oppositely disposed bend pair over a second bend pair
circumferentially offset from said first bend pair.
19. The assembly of claim 8, wherein: said expandable tubular body
having an outer wall and said sheath extends over at least a
portion of said outer wall so that said sheath contacts the lumen
in the larger dimension of said expandable tubular body; said lumen
is occluded when said body reaches said larger dimension placing
said sheath in contact with the lumen.
20. The assembly of claim 1, wherein: said expandable tubular body
further comprises generally radially extending prongs to engage the
lumen is said larger dimension for fixation of said expandable
tubular body; said prongs disposed adjacent said proximal end of
said expandable tubular body and extending in a direction away from
said distal end
Description
FIELD OF THE INVENTION
[0001] The present invention relates to an endo-luminal occluding
device, which when implanted within a body lumen, such as arteries,
veins, fallopian tubes, facilitates immediate occlusion of the
lumen. By this means blood supply to tumors, necrotic tissues, and
aneurisms can be cut off immediately and help in healing of the
affected areas of interest. Similarly an immediate blocking of the
fallopian tubes will prevent sperm migration preventing the
fertilization of the ovum and hence will provide means of immediate
female sterilization.
BACKGROUND OF THE INVENTION
[0002] The present invention deals with a method and device that
will occlude the body lumen immediately and does not depend of
tissue growth to cause the occlusion of the body lumen. Occlusion
of body lumens for various medical procedures as well as for female
sterilization is a very common practice and is performed frequently
throughout the world except in most cases the procedure depends of
tissue growth due to the tissue injury to affect closure, which
takes time. Often additional tests are conducted at a later date,
with additional expenditure, to assure, a closed lumen. Cutting
blood supply to tumors is often used to shrink the tumor and
similarly cutting blood supply can also alleviate neuropathic pain
in the clinical practice. For female sterilization, various devices
have been developed in the past and these methods depend on tissue
growth within the lumen caused by injury and/or irritation of the
fallopian tube tissue by an implanted device for its closure.
Additionally, the most common female sterilization method is
fallopian tube ligation, a procedure that utilizes a
trans-abdominal approach for the occlusion, or tying, of the
fallopian tubes, which is surgical, and expensive. Despite its
worldwide use, tubal ligation via the trans-abdominal approach is
associated with substantial trauma, discomfort, hospital stays, and
complications, such as bleeding, infection, reactions to general
anesthetic, and bowel perforation. The trans-abdominal approach
involves surgery, and is not readily available to many women
throughout the world. Even though local anesthetic is considered an
option for the trans-abdominal approach to tubal ligation, almost
all of these sterilization procedures are performed under general
or spinal anesthesia. In addition, the trans-abdominal approach to
tubal ligation requires incisions that invade the peritoneal
cavity, thereby raising the risk of injury to intra-abdominal
structures.
[0003] In order to avoid the problems associated with
trans-abdominal tubal ligation procedures, various trans-cervical
approaches to tubal sterilization have been proposed. The
trans-cervical approach to sterilization involves the insertion of
a catheter or sterilization device directly into the fallopian
tubes via the reproductive tract, eliminating the need for general
anesthetic and abdominal incisions. Initial trans-cervical
approaches to tubal sterilization involved radiofrequency, chemical
or heat induced scarring, or liquid silicone injections. However,
these approaches have all failed due to safety and efficacy
concerns. Chemical scarring agents, such as quinacrine, iodine, and
methylcyanoacrylate, require repeated applications and have
problems concerning biocompatibility. Thermal blocking procedures,
which induce the formation of scar tissue within the fallopian
tubes, have high failure rates and major complications such as
uterine bleeding and bowel perforation. Electrocautery methods,
which employ an electric current to induce scar tissue within the
fallopian tubes, are also unsatisfactory because they do nor scar a
sufficient amount of tissue and because they can burn surrounding
organs, particularly the bowel.
[0004] Current trans-cervical methods involve occluding the
fallopian tubes by implanting a small occluding device. The
occluding devices in the prior art are usually in the form of a
cylindrical plug or a coil. For instance, Loy in U.S. Pat. No.
6,357,443 describes a removable fallopian tube plug consisting of a
tubular (cylindrical) elongate member with a number of fingerlike
protrusions that extend radially outwards creating a barrier and
thereby occluding the fallopian tubes. Additionally, Saadat et al.
in U.S. Pat. No. 5,935,137 describe a fallopian tube occluding
device for female sterilization which is a plastic, rubber, or
metal elongate hollow tubular (cylindrical) structure with ribs
that are either coated with copper or are interlaced with copper
rings. The hollow portion of this device has a valve, or seals with
a hydrogel, after the device is implanted into the fallopian
tubes.
[0005] Coils, which have a helical outer surface and which assume a
bent shape when released from the delivery catheter system, are
also used to occlude the fallopian tubes. For example, Ton et al.
in U.S. Pat. Nos. 5,601,600 and 5,746,769 describe the use of a
coil to occlude the fallopian tubes. The device consists of
polyethylene terephthalate (PET) fibers wrapped around a stainless
steel core that is surrounded by 24 or more coils of
nickel-titanium alloy. After the device is deployed within the
fallopian tubes, the PET fibers induce the tubal epithelium to
undergo fibrosis, which results in tubal occlusion. The device also
relaxes to its natural bent shape once it is deployed in the
fallopian tube. The tubal occlusion process from these devices
takes about three months to complete and must be confirmed via a
hysterosalpingogram.
[0006] U.S. Pat. No. 7,846,160 teaches the use of an exterior screw
thread to advance a lumen plug by rotation In FIG. 3. In FIG. 4
barbs are held under a sheath such that when the sheath is
retracted, the barbs spring out and point proximally to prevent
removal.
[0007] Most of these devices eventually become dislodged or have
found to be only moderately effective in preventing pregnancy. In
addition, all of the fallopian tube occluding devices are either
composed of metal or have metal components. As a result, various
surgical procedures involving electrosurgery, radiofrequency, or
microwave energy cannot be performed near the implants. Therefore,
a need exists for a female contraceptive device that does not
contain any metal, does not migrate once implanted, and which
provides immediate protection against conception. The occlusion
device of the present invention fulfills these needs.
SUMMARY OF THE INVENTION
[0008] The present invention consists of a permanent acute
occlusion implantable device and method for immediate occlusion of
a body lumen, such as the blood vessels, aneurisms, or the
fallopian tubes of the human female. The implant, an acute
occlusion device, consists of a small narrow low profile slotted
tube (stent) and which carries a hemi-spherical or conical-shaped
structure, which is a continuation of the struts of the slotted
tube, that is located near the distal end of the small narrow
slotted tube, the struts of which are at least in part encased in
an expandable sheath, which can function as an occlusion means for
a body lumen when it is expanded using an inflatable balloon.
[0009] The occlusion means described in the present invention is
permanently placed inside a body lumen for occlusion of the body
lumen. The device is delivered using a balloon where the occlusion
element is crimped onto a balloon. The delivery catheter is
threaded into the appropriate location either through a sheath or
through a hysteroscope and the balloon is inflated to deliver the
occlusion device into place causing immediate occlusion of the
lumen.
[0010] The small narrow slotted tube (or the stent) is made from a
metallic tube by cutting appropriate slots, or openings, on its
surface, so that expanding of the slotted tube using an inflating
balloon as previously described, yields a structure that is several
times larger than its original diameter and continues to remain at
its final expanded diameter, depending on the diameter of the
inflating balloon. The material of the slotted tube (stent) will
undergo deformation beyond its yield point and therefore will
remain at or near its expanded condition. Often, a slightly higher
inflating diameter may be required to achieve the final diameter
needed for the expanded slotted tube for a given application. The
initial diameter of the slotted tube is substantially small (less
than 2 mm) so that the initial profile of the slotted tube and the
entire device is small enough to thread through a delivery device
catheter or a hysteroscope depending on the purpose of its use. The
slots or openings on the surface of the slotted tube can be
lengthwise or at an angle to its longitudinal axis. The number of
slots around its diameter also depends on the surface available on
the slotted tube for providing sufficient slots. The slots can be
arranged in many different configurations having the general
sinusoidal or triangular undulations or any other shape that would
make the slotted tube flexible. The width and the length of the
slots are determined by the initial diameter, hence the surface
area, of the slotted tube and the ratio of the expanded and the non
expanded diameter of the slotted tube.
[0011] The slotted tube is mounted on a balloon by crimping on to
the deflated (and folded) balloon typically by using a crimping
means available for this purpose in the industry. The balloon
material chosen shall be such that the balloon inflates to a
pre-determined fixed diameter at a given inflation pressure.
Typically a balloon made from nylon, PET or similar material is
suitable for this purpose. The balloon catheter will have a
relatively small shaft such as 2 French and will have sufficient
stiffness and flexibility that allows optimal push-ability and
track-ability characteristics.
[0012] The slotted tube or stent is encased in a bio-compatible
expandable material, such as silicone, polyurethane or any other
soft, expandable polymeric or biological material that can be used
to encase the stent and the conical structure at the distal end of
the occluding device. The encasing material shall be well bonded to
the metallic struts of the slotted tube and the struts of its cone
and shall not separate from the struts during expansion by the
inflating balloon.
[0013] The occlusion device is provided with one or more
protrusions, arising from the undulating segments, which are placed
on the slotted tube body, which upon expansion will embed into the
tissue to anchor the occlusion device into the inner wall of the
occluding lumen. These protrusions can be placed anywhere along the
largest diameter section of the occluding device.
[0014] Additionally the inflating balloon can be so made having a
waist region in the middle area such that when the slotted tube is
expanded, the slotted tube takes the shape of the balloon into a
dumb-bell appearance. This feature allows the slotted tube to
physically lock into the lumen tissue and will prevent the
migration of the occluding device within the occluding lumen.
[0015] Another means to anchor would be to use an inflating balloon
which has a larger diameter at its proximal end than the distal
end. Thereby the expanded stent will have a larger diameter
proximally than distally. When properly placed, the expanded
portion of the slotted tube, which is larger than the rest of the
slotted tube can be located at the ostium of the lumen, thereby
preventing the occluding device migrating further deep into the
occluding lumen.
[0016] The slotted tube generally has several undulating or
sinusoidal segments that are connected with flexible connecting
strut members. The connecting strut members can be straight,
parabolic or sinusoidal and may have more than one tangent thereby
creating a curved strut. The connecting struts can be very short
(less than 0.5 mm) or long (more than 0.5 mm). The preferred
embodiment will consist of two undulating rings in the slotted tube
that is connected by a strut which is 3-5 mm long. The distal
undulating ring continues to form a conical or hemispherical
structure, which may be attached to a short guide wire at its
distal end. The guide wire helps the track-ability of the device,
in the event the lumen has complex and multiple curvatures or when
the lumen takes off at an angle at the ostium. Typically the distal
undulating segment and the conical portion are encased in the
expandable membrane, which is impervious to body fluids, such as
blood or semen.
[0017] Once the occluding device is properly delivered, a hermetic
seal is made between the distal undulating segment of the occluding
device and the inner wall of the lumen preventing fluid passage.
The cone portion having encased struts is also completely
impervious to any fluids and therefore no fluid passes through the
cone section of the occluding device. The space between the two
undulating segments is connected by a few struts (typically four)
providing the special benefit in anchoring the device in the lumen
as the inner wall of the lumen as the tissue will prolapse through
the struts affixing the occlusion device in the lumen.
[0018] The encasing materials, such as silicone usually have
elastic properties. As such when the slotted tube is expanded,
there is some degree of recoil (back) of the slotted tube, which
may cause an improper hermetic seal. Therefore the slotted tube can
be designed to have two different diameters with one portion
overlapping the other. This will allow less elastic deformation of
the encasing material and therefore less recoil of the stent after
delivery. This is accomplished by using a crimping technique
whereby the struts at 12 o'clock and 6 o'clock are crimped first on
the balloon and the struts orthogonal to them, i.e. the struts at 3
and 9 o'clock are crimped over the struts that were previously
crimped. During inflation of the balloon, the encased slotted tube
first unfolds and then expands slightly to its maximum desired
dimension. This low expansion will reduce the recoil and help in a
more reliable sealing of the slotted tube into the inner wall of
the lumen.
[0019] The above described device is a balloon delivered occlusion
device, which is made from a slotted tube encased with an
expanding, yet impervious membrane. Upon delivery and the occluding
device is anchored in the lumen and provides an occluding "wall"
completely closing the lumen and preventing the flow of fluids
across the device. As such, this device and various modification of
it will provide permanent occlusion of a body lumen when properly
implanted in a body lumen. The advantage of the present invention
is that immediate hermetic seal and a complete occlusion of the
lumen are achieved by the proper placement of the lumen occluding
device. This device does not depend on tissue growth to close the
lumen, which not only takes time but in some instances not very
reliable and does not require a test after a few weeks to check for
the efficacy of occlusion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 shows the lumen occluding stent device.
[0021] FIG. 2 shows the lumen occluding stent device mounted on to
a delivery catheter.
[0022] FIG. 3 shows a delivery catheter balloon (inflated) having a
waist region, on which a lumen occluding stent device can be
mounted.
[0023] FIG. 4 shows a cross section of an alternate way to fold and
crimp a lumen occluding stent on to a balloon.
[0024] FIG. 5 shows the lumen occluding stent device with the
balloon inflated to the desired diameter.
[0025] FIG. 6 shows the lumen occluding stent device mounted onto a
balloon with a waist with the balloon inflated showing the form of
the lumen occluding stent device, after balloon inflation.
[0026] FIG. 7 shows a lumen occluding stent device mounted onto a
balloon having a larger diameter at the balloon's proximal end, and
the stent expanded taking the shape of the balloon.
[0027] FIG. 8 shows a lumen occluding stent having a proximal
section expanded to a larger diameter than the rest of the stent
using a balloon having a larger proximal portion.
[0028] FIG. 9 shows the lumen occluding stent device placed in the
ostium of the fallopian tube of the human female.
[0029] FIG. 10 shows the lumen occluding stent device having only
two segments connected by long struts placed in the ostium of the
fallopian tubes of the human female, also showing the tissue
prolapse.
DETAILED DESCRIPTION OF THE PREFFERED EMBODIMENT
[0030] FIG. 1 shows the lumen occluding stent (10) made from a
slotted tube with a guide wire (30) attached to its distal end. The
tube can be solid or open shape made of elongated members. Although
slots are preferred other shapes are contemplated including scoring
the tubular wall so that expansion of the wall dimension meets less
resistance and could also open along the score lines. A typical
diameter of the stent portion is about 1.5 mm and a typical guide
wire diameter shall be 0.035 inch. The guide wire shall be flexible
and it can be made from stainless steel, cobalt chromium steel, or
nickel containing steel. The guide wire can also be provided with a
core wire at its center (not shown). The guide wire is attached to
the stent portion by various attachment means such as adhesive
bonding or welding. The guide wire can also be an integral part of
the stent struts (40). The stent (10) is attached to the guide wire
(30) by four to six struts (20). Struts (20) are a continuation of
the stent (10). The stent described herein can be made by laser
cutting, chemical etching or other machining means. The stent (10)
of the shape and form can also be made from round or rectangular
wire material. Wire material can be folded into sinusoidal form and
the ends thereof can be welded to form the "sinusoidal rings" or
"undulations" (16). These sinusoidal rings (undulations) are
connected to each other by the struts (50). The struts (50) can be
straight or may contain a varying tangent and thereby giving it a
curvature. The lumen occluding stent has openings (60) cut out or
scored to make the stent expandable and flexible. The design of the
nature of the openings (60) will alter the radial strength and the
flexibility of the stent. When more openings are designed into the
slotted tube stent, can be straight slots or slots with curvatures,
and less metal content will be left in the stent and hence will
have less radial strength. When less openings are designed into the
stent, the stent will be more rigid and will have more radial
strength but less flexible. Depending on the end use application of
the occluding stent, proper balance of the openings or scores and
strut mass can be made to achieve the desired result.
[0031] In FIG. 2, the slotted tube (10) is encased at least in part
in a sheath of expandable material (90). When the stent is deployed
to a lumen that will be occluded, the slotted tube is expanded
using a balloon (70) in FIG. 2. The expanding material remains
attached to the stent struts and forms a wall across the lumen and
hence completely occluding the lumen. The stent struts act as a
scaffolding support for the expanding material wall of the expanded
material. The sheath 90 can lay over the distal end of the tube 10
or over the distal end and some of the side wall of the tube 10
leaving some or none of the side wall of the tube 10 uncovered. In
this case the sheath material is over the stent body and not
encasing the struts. On expanding the stent the sheath will be
pushed against the lumen wall, sealing the lumen.
[0032] FIG. 2 shows the lumen occluding stent (10) which has been
crimped onto a balloon catheter (80) which is similar to an
angioplasty balloon. The balloon catheter has a shaft (80), with
sufficient stiffness that will allow the operator to push and
advance the catheter into the lumen that will be occluded, yet has
a portion (82) proximal to the balloon that is flexible enough to
give it track-ability characteristics enabling the advancement of
the occluding device into the lumen. The balloon (70) itself can be
made from any of the usual material used for angioplasty balloons,
such as nylon, Polyethylene terapthalate (PET), polyethylene, and
other materials that are able to form into a balloon that is
relatively strong and has low distensibility characteristics. FIG.
3 shows a shape of the balloon catheter (80) having a balloon (70)
which has a waist region (72). The balloon catheter may also
provide a neck region (82) proximal to the balloon for added
flexibility and for improved track-ability. The balloon waist
described herein defines an area which has a diameter less than the
diameter of the rest of the balloon in general. When the lumen
occluding stent (10) is crimped on to the balloon (70) previously
described having a neck region (82) and delivered into the lumen
that is to be occluded. The deployed occluding stent takes the
general shape of the balloon which has a neck region (82). Thereby
imparting a neck region in the occluding stent, and which helps to
anchor the stents in the body lumen.
[0033] FIG. 4 shows an alternate method of folding the encased
slotted tube stent (10) where the two opposite undulations (12) are
crimped first and the orthogonal undulations (14) are crimped next
so that one set of undulations overlaps the other set of
undulations. By this means the degree of expansion of the encased
material is much less and therefore will produce an expanded lumen
occluding stent with less recoil. This is because the material
undergoes lesser degree of deformation and as a result, due its
larger initial perimeter and therefore is subjected to less strain
and hence less recoil.
[0034] FIG. 5 shows a deployed (in its expanded state) lumen
occluding stent (10) with the inflating balloon (70) within it. The
struts of the stent are encased within the encasing material (90)
and are impervious to fluids including blood or semen. Typically
the encasing material (90) may encase only the most distal
undulations of the lumen occluding stent.
[0035] FIG. 6 shows a lumen occluding stent expanded by a delivery
catheter balloon having a waist region (72), which has a diameter
less than the rest of the balloon. When the stent is delivered into
the lumen with such a balloon, the stent takes the general shape of
the balloon. The balloon instead of having a waist may contain a
bulge or a larger diameter, having an egg shape. Once the delivery
catheter (80) is removed the stent shape remains allowing the
tissue to prolapse into the stent and hence anchoring the stent
into place. This will prevent the lumen occluding stent (10) from
migrating from the position it was placed.
[0036] FIG. 7 shows another type of inflating balloon (70) having a
larger diameter (76) at its proximal end. When a lumen occluding
stent is expanded using such a balloon, the proximal end (16) of
the stent will expand generally to match the balloon. This type of
delivery balloon (70) will be useful when the lumen occluding stent
is placed at the entrance to a lumen such as a blood vessel arising
from the aorta or the fallopian tube arising from the uterus. When
such expansion occurs, the stent (10) will not migrate further into
the lumen because of its expanded proximal end.
[0037] FIG. 8 shows a lumen occluding stent (10) with the proximal
struts (16) expanded with a balloon described in FIG. 7. The
encapsulating sheath (90) generally covers the entire stent except
the expanding strut region (16). This feature will enable the lumen
occluding stent to anchor into the tissue. Alternatively the
encapsulating sheath (90) may cover only the most distal
undulations of the lumen occluding stent and the adjacent cone or
hemispherical region of the occluding stent.
[0038] FIG. 9 shows the described lumen occluding stent (10) in
FIG. 8 within the fallopian tubes of the human female. The
expanding struts (16) are in the uterus and the occluding stent is
within the fallopian tube. The sheath (90) encasing the lumen
occluding stent is pressed against the inner wall of the fallopian
tube in the stent region and encases the conical region, thereby
completely occluding the lumen and forms a hermetic seal completely
occluding the lumen immediately after the lumen occluding stent is
deployed into the body lumen. FIG. 10, shows a similar lumen
occluding stent, having only two undulations (16) connected by a
longer connecting struts (50). The connecting struts are generally
1-5 mm long. The proximal undulation (16) is not encased in a
sheath, but the second more distal undulation (16) and the adjacent
cone (20) area are encased with the encasing material (90). The
advantage of this lumen occluding stent is, once the stent is
delivered, the inner wall tissue (104) can prolapse in between the
longitudinal struts (50) and thereby locking and anchoring the
stent in place, which will prevent the stent from migrating after
placement. It is also possible to provide more than one undulation
in the proximal region as well as at the distal region of the lumen
occluding stent (10). The number of undulations used will
essentially depend of the application, depending whether sufficient
lumen length is available to place a longer lumen occluding stent
and other criteria related to the lumen to be occluded.
* * * * *